Mölndal, Sweden, 17 September 2026 – Integrum AB (publ) (Nasdaq First North Growth Market: INTEG B) today announces that the first patient in the U.S. clinical development program for the e-OPRA™ Implant System has undergone surgery in which the implant was anchored into the bone and electrodes were placed on muscles and around nerves. The procedure was performed at Northwestern Memorial Hospital under an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA). The study is the first of its kind and is expected to inform the future development of implantable intelligent bionics.
The study is led by the Regenstein Foundation Center for Bionic Medicine at Shirley Ryan AbilityLab, one of the leading rehabilitation hospitals in the United States and is being conducted in collaboration with Northwestern Medicine and the University of Chicago. It is the first study to combine osseointegration, targeted muscle reinnervation (TMR), a surgical technique that reroutes nerves, and pattern-recognition control using implanted sensors that record the electrical activity generated in the muscles (EMG), together with nerve electrodes that provide sensory feedback. Eight patients will be enrolled in total, and the study is expected to conclude in 2030, at which point the results will be made publicly available.
The study is funded by an award of USD 8.7 million from the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), and marks an important step in strengthening the clinical evidence base for e-OPRA.
"Being in the operating room when e-OPRA was implanted in the first patient in the United States was a significant milestone for Integrum. Shirley Ryan AbilityLab and Northwestern Medicine are among the world's foremost institutions in rehabilitation medicine and reconstructive surgery respectively, and we look forward to our continued collaboration to evaluate and improve the performance of the system," says Rickard Brånemark, Chief Medical and Scientific Officer at Integrum.
"It is highly encouraging to see the program at Shirley Ryan AbilityLab advancing. e-OPRA builds on the value of our bone-anchored implants and addresses an area of growing interest: connecting the body to the prosthesis through skeletal anchoring, the decoding of muscle signals and restored sensory feedback. If the program succeeds, it will open new possibilities for people with limb loss to regain both mobility and sensation," says Martin Hillsten, CEO of Integrum.
For more information, please contact:
Martin Hillsten, CEO
Tel: +46 733 55 28 32
Email: martin.hillsten@integrum.se
Certified Adviser
DNB Carnegie Investment Bank AB (publ)
+46 8-588 685 70
certifiedadviser@dnbcarnegie.se
About Us
Integrum AB is a publicly traded company (INTEG B: Nasdaq First North Growth Market) based outside of Gothenburg, Sweden. Since 1990, its OPRA™ Implant System has helped improve the quality of life for hundreds of people who are amputees by directly attaching a prosthesis to the bone and musculoskeletal system, therefore eliminating the need for a socket. Based on osseointegration, the bone-anchored implant system offers a range of benefits, including improved mobility and function, enhanced comfort, reduced pressure, a stable attachment and more. The OPRA™ Implant System was approved by the U.S. Food and Drug Administration (FDA) in 2020 and is the only FDA-approved bone-anchored implant system specifically designed for use in amputees available in the U.S. Today, Integrum continues to perform research and develop custom-made medical device solutions in close collaboration with scientists and clinicians. To learn more, please visit https://integrum.se/.